Brief Summary
This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of RO4905417 in patients with non ST-elevation myocardial infarction (Non-STEMI) undergoing percutaneous coronary intervention (PCI). Patients will be randomized to receive an intravenous infusion of either 5 mg/kg RO4905417 or 20 mg/kg RO4905417 or placebo before PCI. Follow-up will be for 4 months.
Brief Title
A Study of RO4905417 in Patients With Non ST-Elevation Myocardial Infarction (Non-STEMI) Undergoing Percutaneous Coronary Intervention
Categories
Completion Date
Completion Date Type
Actual
Conditions
Myocardial Infarction
Eligibility Criteria
Inclusion Criteria:
* Adult patients, \>18 to \<75 years of age
* Non ST-elevation myocardial infarction
* Woman of childbearing potential will be allowed only if using two acceptable methods of contraception
* Body mass index (BMI) \</= 40 kg/m2
Exclusion Criteria:
* Acute ST-elevation myocardial infarction (STEMI)
* Culprit coronary lesion with a total thrombotic occlusion or a lesion requiring the use of distal embolization protection or thrombectomy devices
* Percutaneous coronary intervention (PCI) within the past 72 hours
* Thrombolytic therapy within the past 7 days
* Major surgery within the past 3 months
* History of cerebral vascular disease or stroke in the past 3 months
* Bleeding disorders
* Inadequately controlled severe hypertension
* Prior coronary artery bypass graft (CABG) surgery
* Decompensated heart failure (oedema and/or rale)
* Acute infection at screening or active chronic infection within 3 months prior to PCI
* Patients known to be HIV positive, patients receiving antiretroviral drugs, or immuno-suppressed patients
* Uncontrolled diabetes mellitus (HbA1C \>10%) at baseline
* Adult patients, \>18 to \<75 years of age
* Non ST-elevation myocardial infarction
* Woman of childbearing potential will be allowed only if using two acceptable methods of contraception
* Body mass index (BMI) \</= 40 kg/m2
Exclusion Criteria:
* Acute ST-elevation myocardial infarction (STEMI)
* Culprit coronary lesion with a total thrombotic occlusion or a lesion requiring the use of distal embolization protection or thrombectomy devices
* Percutaneous coronary intervention (PCI) within the past 72 hours
* Thrombolytic therapy within the past 7 days
* Major surgery within the past 3 months
* History of cerebral vascular disease or stroke in the past 3 months
* Bleeding disorders
* Inadequately controlled severe hypertension
* Prior coronary artery bypass graft (CABG) surgery
* Decompensated heart failure (oedema and/or rale)
* Acute infection at screening or active chronic infection within 3 months prior to PCI
* Patients known to be HIV positive, patients receiving antiretroviral drugs, or immuno-suppressed patients
* Uncontrolled diabetes mellitus (HbA1C \>10%) at baseline
Inclusion Criteria
Inclusion Criteria:
* Adult patients, \>18 to \<75 years of age
* Non ST-elevation myocardial infarction
* Woman of childbearing potential will be allowed only if using two acceptable methods of contraception
* Body mass index (BMI) \</= 40 kg/m2
* Adult patients, \>18 to \<75 years of age
* Non ST-elevation myocardial infarction
* Woman of childbearing potential will be allowed only if using two acceptable methods of contraception
* Body mass index (BMI) \</= 40 kg/m2
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Maximum Age
74 Years
Minimum Age
19 Years
NCT Id
NCT01327183
Org Class
Industry
Org Full Name
Hoffmann-La Roche
Org Study Id
BP25619
Overall Status
Completed
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF 2 DOSES OF RO4905417 (R1512) ADMINISTERED TO PATIENTS WITH NON ST-ELEVATION MYOCARDIAL INFARCTION (NON-STEMI) UNDERGOING PERCUTANEOUS CORONARY INTERVENTION (PCI)
Primary Outcomes
Outcome Measure
Reduction of procedural damage during percutaneous coronary intervention (PCI): Change from baseline in troponin I levels early after PCI
Outcome Time Frame
from baseline to 24 hours post PCI
Secondary Outcomes
Outcome Time Frame
from baseline to 8 hours post PCI
Outcome Measure
Change from baseline in troponin I at 8 hours post PCI
Outcome Time Frame
24 hours post PCI
Outcome Measure
Peak and AUC for troponin I
Outcome Time Frame
from baseline to 24 hours post PCI
Outcome Measure
Change from baseline in Creatine Kinase-Myocardial Band (CK-MB) after PCI
Outcome Time Frame
from baseline to Day 120 post PCI
Outcome Measure
Change form baseline in Growth Differentiation Factor 15 (GDF-15) at 120 days post PCI
Outcome Time Frame
from baseline to Day 30 post PCI
Outcome Measure
Change from baseline in cystatin C biomarker at 24 hours and 30 days post PCI
Outcome Time Frame
120 days
Outcome Measure
Safety: Incidence of adverse events and major adverse cardiovascular events (MACEs)
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
74
Minimum Age Number (converted to Years and rounded down)
19
Investigators
Investigator Type
Principal Investigator
Investigator Name
Vankeepuram Vankeepuram
Investigator Email
Investigator Phone